Kornimate/medical-research-clean huggingface dataset:
a multicenter, randomized, double-blind, placebo-controlled study of abt-494 for the induction of symptomatic and endoscopic remission in subjects with moderately to severely active crohn's disease who have inadequately responded to or are intolerant to immunomodulators or anti-tnf therapy

Conditions: Crohn's Disease

Summary: to determine the efficacy and safety of multiple doses of abt-494 in subjects with moderately to severely active crohn's disease with a history of inadequate response to or intolerance to immunomodulators or anti-tumor necrosis factor (tnf) therapy.


Eligibility criteria:
inclusion criteria: 1. diagnosis of crohn's disease (cd) for at least 90 days. 2. crohn's disease activity index (cdai) greater than or equal to 220 and less than or equal to 450. 3. subject inadequately responded to or experienced intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-tnf agent (e.g., infliximab, adalimumab, or certolizumab pegol). exclusion criteria: 1. subjects with ulcerative colitis (uc), collagenous colitis or indeterminate colitis. 2. subject who has had surgical bowel resections in the past 6 months or is planning resection. 3. subjects with an ostomy or ileoanal pouch. 4. subject with symptomatic bowel stricture or abdominal or peri-anal abcess. 5. subject who has short bowel syndrome. 6. subject with recurring infections or active tuberculosis (tb).

Keywords: crohn's disease
comparative study of azasite plus compared to azasite alone and dexamethasone alone to treat subjects with blepharoconjunctivitis

Conditions: Blepharoconjunctivitis

Summary: the purpose of this study is to determine if azasite plus is effective and safe for the treatment of blepharoconjunctivitis compared to azasite alone and dexamethasone alone.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of blepharoconjunctivitis * must be willing to discontinue contact lens wear for the duration of the study * have best corrected visual acuity of 6/24 in both eyes * have iop less than or equal to 25 mmhg in either eye exclusion criteria: * have known sensitivity or poor tolerance to any component of the study medications * have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months * have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study * have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment * use of any eye make-up during the study * have any uncontrolled systemic disease or debilitating disease * have been diagnosed with glaucoma * have any clinically significant cardiovascular disorders * have any history of liver or kidney disease resulting in persisting dysfunction * have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device

Keywords: blepharoconjunctivitis, ophthalmology
written exposure therapy for ptsd in a virtual, group-based format

Conditions: Post Traumatic Stress Disorder

Summary: the purpose of this study is to examine whether written exposure therapy (wet) can be effectively delivered virtually and in a group format for the treatment of post-traumatic stress disorder in a military and police population. the objective of this study is to assess treatment feasibility and acceptability, drop out rates, changes in severity of trauma-related symptoms and symptoms of depression, quality of life, and the need for further trauma-focused treatment (tft) for the the delivery of wet as a virtual, group based intervention.

this study will assess the efficacy and acceptability of wet being delivered virtually and in a group format for the treatment of ptsd through the operational stress injury clinic (osic) at deer lodge centre. wet is offered in small groups of 10 patients. this study will follow 8 iterations of the group for a potential total of 80 participants in this study. each wet group session will be facilitated by two osic clinicians, at least one of whom will be a clinical psychologist. each session, administered via the zoom app for healthcare, will start with a brief check in, then instructions will be provided to the whole group. each group will receive a total of 5 therapy sessions, each of which will last approximately 1.5hrs. prior to the first wet session, participants will be asked to complete three clinical measures: patient health questionnaire- 9 (phq-9), ptsd checklist for dsm-5 (pcl-5, weekly version), and outcome questionnaire-45 (oq-45). participants will be asked to complete the pcl-5 prior to each session. participants will also complete a treatment acceptability/adherence scale prior to the start of the second session. following the final session of therapy, participants will be asked to complete the three clinical assessment questionnaires (phq-9, pcl-5, and oq-45) at 1 week, 1 month, and 3 months post-treatment. a research assistant will also follow-up with each participant at the 3-month mark to ask whether they have sought or attended further psychological treatment since the end of the wet sessions.

Eligibility criteria:
inclusion criteria: * referred for written exposure therapy at the occupational stress injury clinic (osic) in winnipeg * able to speak, read, and write in english * medication held at a stable dose for four weeks prior to beginning treatment and throughout the duration of treatment (if on a prescribed medication) exclusion criteria: * current psychosis * presence of another psychiatric disorder that requires prioritization over treating ptsd * any cognitive, visual, or motor impairment that would prevent writing for 30 minutes
yoga for chronic headache in adolescents

Conditions: Tension Type Headache; Migraine

Summary: a randomized controlled trial to investigate the efficacy of yoga on tension type headache and / or migraine in adolescents between 12 and 16 years, consisting of a four group design which includes an 12 week yoga course and a three-month follow-up period. both adolescent and one parent will be randomized either to yoga or no treatment. primary outcome will be pain frequency in adolescents considering pain catastrophizing of parents.


Eligibility criteria:
inclusion criteria: adolescent: * tension type headache and/or migraine minimum at 4 days per month * willingness to participate at least 10 out of 12 yoga sessions * physical and cognitive ability to participate in light physical, breathing and relaxation exercises * good german language parents: * willingness to participate at least 10 out of 12 yoga sessions * physical and cognitive ability to participate in light physical, breathing and relaxation exercises * good german language exclusion criteria: * pregnancy or lactation * attending a yoga class within the last 3 months prior to the study
cervical cancer self-collection for southeast asian immigrant and refugee women

Conditions: Cervical Cancer Screening

Summary: the primary purpose of this study is to determine whether educational workshops paired with self-collected high-risk human papillomaviruses (hrhpv) screening will increase participation in cervical cancer screening among southeast asian immigrant and refugee populations in wisconsin compared with offering clinician collected screening (total sample size: 250 participants). the investigators hypothesize that participation in cervical cancer screening will be higher among women in the intervention group as compared to the control group.

the effectiveness of offering self-collection sampling options to southeast asian refugee and immigrant populations to improve cervical cancer screening participation has not been investigated. the milwaukee consortium for hmong health (mchh), supported by the well woman program, has had success increasing participation in breast cancer screening through outreach and education activities. however, it continues to have limited success engaging women in cervical cancer screening. the investigators have established a partnership with mchh to develop innovative cervical cancer workshops that combine community health worker (chw)-led engagement with self-collected hrhpv screening, with the primary objective of increasing participation, awareness, and engagement in cervical cancer screening and treatment activities among this population. research intervention: control workshops are workshops where participants are provided education on standard-of-care for cervical cancer screening such as pap smear and hpv testing through clinician-collection methods using speculum and cervical swabs. intervention workshops are workshops where participants are provided all the same education as control as well as additional education on self-collection for hpv-only testing using vaginal swab as an additional method. after each workshop, each group will be offered to participate in their assigned group's screening method (clinician-collected or self-collected). * primary objective: to evaluate whether educational workshops paired with self-collected hrhpv screening will increase participation in cervical cancer screening among southeast asian refugee and immigrant populations in wisconsin compared with offering clinician-collected screening. * secondary objectives: to evaluate participant satisfaction with the educational workshops using satisfaction surveys.

Eligibility criteria:
inclusion criteria: * fluent understanding in english, hmong, karen, burmese, or karenni exclusion criteria: * prior hysterectomy * impaired decision-making capacity * pregnancy

Keywords: self-collection community health workers
exercise and steroid in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: osteoarthritis (oa) of the knee is a very common chronic joint disorder associated pain and disability. as no cure exists, management aims to reduce pain, improve function, and enhance quality of life. the recommended hierarchy of management should consist of exercise in first line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery. the effect size of exercise therapy is of the same magnitude as most pharmacological treatments but is often without adverse effects. local pharmacological treatment of the afflicted knee joint is recommended by means of intra-articular injections of corticosteroids, which is considered as a standard medical treatment of knee oa and are included in established guidelines for management of knee oa. while the two treatment approaches have been investigated separately in numerous clinical trials, the efficacy of a combined pharmacological and non-pharmacological approach is not known, despite the high rank of such combined treatment approach on the recommended hierarchy of management. the purpose of this study is to assess the effects of exercise therapy in combination with intra-articular corticosteroid injections on patient reported pain and function in patients with knee oa. the hypothesis is that the combined treatment approach (exercise therapy preceded by intra-articular injection of corticosteroid) enhances the clinical outcome compared to exercise therapy preceded by a placebo injection.


Eligibility criteria:
inclusion criteria: * age 40 years or above * clinical knee osteoarthritis verified by radiography * pain during level walking of at least 40 mm on a 0-100 mm visual analog scale * clinical signs of local inflammation * body mass index between 20 and 35 exclusion criteria: * exercise therapy within 3 months * intraarticular corticosteroid within 3 months * counter indications to exercise * counter indications to corticosteroid * pregnant or breast feeding * auto immune disease * planned surgery in the study period * significant cardiovascular disease * significant neuroloigal disease * significant psychiatric disease * regional pain syndromes (e.g. fibromyalgia) * spinal nerve root compression syndromes
nurse management of neuromodulation therapy

Conditions: Parkinson's

Summary: the central hypothesis is that the use of a dbs (deep brain stimulation) clinical decision support system for individual patient management will enable considerable time savings compared to standard care. this hypothesis was formulated from pilot studies that showed dramatic decreases in dbs programming time compared to standard care for clinicians who used an ipad-based decision support system (99% time savings from over 4 hours to 2 minutes. study group parkinson's patients with dbs systems

in most cases these subjects have failed to maintain adequate control of their symptoms on medications alone. the diagnosis of pd (parkinson's disease) and the decision to have dbs qualifies a subject for enrollment. subjects would be selected because they will require dbs programming. the investigators will prospectively enroll 20 pd dbs patients at the froedtert movement disorders center (surgical targets: subthalamic nucleus (stn) or internal segment of globus pallidus (gpi). post-operative care, patients will be randomized 1/1 to standard care or using the clinical decision support system. the dbs rn will use imagevis3d mobile app on the ipad to program the dbs system, this software does not interact with froedtert imaging systems. the study team uses identified images provided by the froedtert pacs system, de identifies them, adds a study code. the images are loaded into the software system and used to identify the leads locations. the patients will be assessed for 6 months starting with the initial dbs programming session. importantly, the investigators do not anticipate that the clinical decision support tool will provide the final dbs settings, nor do we anticipate that this approach will obviate the need for motor exams. the clinical decision support system will help nurses choose good initial settings and then explore around those initial settings. the investigators will measure the time spent on dbs programming for patients in each group. the investigators will capture programming session duration, number of programming sessions and total time spent on dbs programming. the investigators will compare total time spent programming for the standard care versus the intervention group.

Eligibility criteria:
inclusion criteria: subjects 18 and older with a diagnosis of parkinson's disease that are scheduled for deep brain stimulation for control of their symptoms and are seen at the froedtert neurology outpatient clinic. exclusion criteria: patient's that are not candidates for deep brain stimulation.
mechanism and treatment of sympathetically maintained pain

Conditions: Complex Regional Pain Syndrome (CRPS)

Summary: 40 crps patients will be recruited over a three-year period (target of 160 patients at all sites). assessment of exclusion criteria will be undertaken during initial recruitment. exclusion criteria are: \<18 years; a second chronic pain syndrome that would interfere with pain rating; psychiatric comorbidity; pain in both hands or feet; pregnancy or breastfeeding; sympathectomy in the affected limb; use of topical medication; known sensitivity to alpha 1- adrenoceptor agonists or other contraindications. patients will maintain their regular oral medications throughout the study period. assessment of sympathetically maintained pain (smp) will require an intradermal dose of phenylephrine to rekindle smp and mechanical hyperalgesia. clonidine will be used to control for affects of algometer fiction and may inhibit smp by inhibiting the release of more norepinephrine from sympathetic nerve terminals. skin biopsies will be obtained under sterile conditions from a site of mechanical or thermal hyperalgesia using a 3mm diameter skin biopsy punch under local anesthesia. samples from a mirror image site on the contralateral body side will also be taken.

patients diagnosed with crps and control subjects will be enrolled in the study. the crps participants will be administered with phenylephrine (day 1) and clonidine (day 2). the control participants will not receive any intervention. the aim of this study is to determine if expression of α1-adrenoceptors (α1-ar) altered in the skin of a subgroup of patients whose pain is associated with increased adrenergic sensitivity after nerve trauma. increased adrenergic sensitivity will be determined by assessing pain in patients after administration of phenylephrine on day 1. expression of α1-ar will be determined by taking skin biopsies on day 2 after administration of clonidine. then, we will compare the expression of α1-ar in patients who were classified as having increased adrenergic sensitivity versus those who were not.

Eligibility criteria:
inclusion criteria: * crps patients exclusion criteria: * \<18 years * a second chronic pain syndrome that would interfere with pain rating * psychiatric comorbidity * pain in both hands or feet * pregnancy or breastfeeding * sympathectomy in the affected limb * use of topical medication * known sensitivity to alpha 1- adrenoceptor agonists or other contraindications

Keywords: complex regional pain syndrome (crps)
the relationship between diaphragm muscle thickness and fibromyalgia

Conditions: Fibromyalgia; Anxiety; Depression; Diaphragm Issues

Summary: fibromyalgia syndrome is characterized by chronic pain, fatigue, sleep problems and functional symptoms. fatigue, anxiety and depression disorders, poor quality of life, sleep disorders, decreased concentration, and impaired cognitive functions are non-specific pain-related symptoms. various studies have reported decreased chest expansion, maximal ventilatory volume and maximal expiratory pressure in fibromyalgia patients with widespread body pain. additionally, dyspnea is a symptom associated with respiratory muscle weakness and is associated with general fatigue. in these individuals, lower data are obtained in daily living activities and general health evaluation surveys. we did not find any study in the literature regarding the relationship between diaphragm thickness and fibromyalgia symptoms. in the light of these data, we aimed to evaluate the thickness of the diaphragm, one of the most important inspiratory muscles, in fibromyalgia patients.

demographic information of all individuals included in the study will be collected. daily living activity will be evaluated with short form-36 (sf-36), fibromyalgia impact questionnaire (fiq), pittsburgh sleep quality questionnaire (psqi) and beck depression inventory. in order to evaluate the respiratory function test in both the fibromyalgia and control groups, three consecutive measurements will be taken with a hand spirometer and the arithmetic average of these three measurements will be recorded. in fibromyalgia and control patients, diaphragm thickness was measured at 8-9 degrees on the right anterior axillary line with a 6-14 mhz linear, conventional ultrasound probe (mindray dc-8, shenzen mindray bio-medical electronics co. ltd., p.r. china) in the supine position. it will be measured at the end of inspiration and expiration from the intercostal space. three measurements will be made and the arithmetic average will be evaluated.

Eligibility criteria:
inclusion criteria: * patients diagnosed with fibromyalgia according to the 2016 acr (american college of rheumatology) diagnostic criteria without any comorbidities (such as liver, kidney failure, dm, rheumatic disease) * patients who underwent pulmonary function test (pft) * patients without pulmonary disease * 18 -50 years old women and men exclusion criteria: * congenital spinal, costal and diaphragmatic anomalies neuromuscular disease * respiratory system diseases that affect lung functions * patients who cannot cooperate with spirometry. * having surgery to the chest wall or spine * those with bmi \> 25 * those with liver, kidney failure, dm, rheumatic disease, neurological disease * individuals \ 50 years old

Keywords: diaphragm thickness activities of daily living
combination therapy with differin® gel 0.3% and duac® (clindamycin/benzoyl peroxide gel) in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: this study is to determine the efficacy and safety of 12 week treatment with differin® gel 0.3% applied in the evening, in combination with duac® (clindamycin/benzoyl peroxide gel) applied in the morning, in subjects with acne vulgaris.

same as above.

Eligibility criteria:
inclusion criteria: 1. subjects with a minimum of 20 inflammatory lesions on the face; 2. subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose; 3. subject has a global severity assessment exclusion criteria: 1. subjects with more than three nodulo-cystic lesions
impact of 0.1% and 0.2% sodium hyaluronate on postoperative discomfort following phacoemulsification surgery

Conditions: Cataract

Summary: primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

participants will be recruited from the cataract service of the university hospital of alexandroupolis (uha), the naval hospital in athens, the papanikolaou general hospital in thessaloniki, and athinaiki general clinic in athens in a consecutive-if-eligible basis. by means of a custom computer randomization program all participants will randomly populate either study group \[who will receive fixed combination of tobramycin and dexamethasone (fctd), (tobradex, alcon, greece) quid for 3 weeks and 0.2 % sodium hyaluronate (hylogel, pharmex, greece) quid for 6 weeks\], and control group \[who will receive tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (hylocomod) quid for 6 weeks\].

Eligibility criteria:
inclusion criteria: * diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - lens opacities classification system iii (locs-3) grading scale exclusion criteria: 1. diagnosis or evidence of dry-eye-disease (ded) 2. iop-lowering medications 3. former incisional surgery 4. former diagnosis of corneal disease 5. diabetes 6. autoimmune diseases 7. mental diseases
a study to investigate efficacy and safety of apremilast 30 mg twice daily (bid) in chinese participants with moderate to severe plaque-type psoriasis (pso)

Conditions: Plaque Psoriasis

Summary: the study aims to evaluate the clinical efficacy of oral apremilast 30 mg bid compared with placebo in chinese participants with moderate to severe pso


Eligibility criteria:
inclusion criteria * chinese participants aged ≥18. * diagnosis of chronic, stable moderate to severe plaque pso for ≥ 12 months before screening. the participant must have spga score ≥ 3, pasi score ≥ 12, and bsa involvement ≥ 10% at both screening and baseline (week 0). * participant is a candidate for phototherapy and/or systemic therapy. exclusion criteria * psoriasis flare within 4 weeks of screening. * evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis. * prior medical history of suicide attempt at any time in the participant's lifetime before screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years. * participant has a malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years. * active tuberculosis or a history of incompletely treated tuberculosis. * history of human immunodeficiency virus (hiv) infection. * prior treatment with apremilast. * female participants of childbearing potential unwilling to use protocol specified method of contraception. * female participants who are breastfeeding or who plan to breastfeed. * female participants planning to become pregnant.

Keywords: apremilast dermatology